YD Bio Business Partner EG Biomed Achieves CAP Accreditation, Advancing U.S. Clinical Testing Capabilities
Rhea-AI Summary
YD Bio (Nasdaq: YDES) announced that its business partner EG BioMed achieved CAP accreditation for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600) on October 10, 2025. CAP accreditation, alongside existing CLIA certification, confirms laboratory quality standards and strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) supporting YD Bio’s DNA methylation-based pancreatic and breast cancer detection programs in the U.S.
YD Bio highlighted that this accreditation positions the companies to expand their diagnostic portfolio for early cancer detection and monitoring. EG BioMed’s Chief R&D Officer presented new circulating cell-free DNA biomarker findings at AACR (September 28–October 1, 2025) relevant to metastatic pancreatic cancer monitoring.
Positive
- CAP accreditation secured for EG BioMed Bothell lab (CLIA #50D2316600)
- Accreditation reinforces ability to deliver LDTs for U.S. market
- AACR presentation Sept 28–Oct 1, 2025 on novel cfDNA biomarker
Negative
- None.
Insights
CAP accreditation for EG BioMed strengthens U.S. lab capabilities and supports YD Bio's diagnostic rollout.
EG BioMed earned CAP accreditation for its CLIA-certified Bothell laboratory (CLIA Certificate #50D2316600), which confirms compliance with high laboratory quality standards and formally aligns operational controls with U.S. clinical-testing norms. This accreditation, combined with existing CLIA status, materially increases the laboratory’s credibility to run laboratory-developed tests (LDTs) that the partnership will use to support YD Bio’s DNA methylation cancer-detection programs and related diagnostics.
The main dependencies are documented: sustained CAP compliance, effective LDT validation within that CLIA/CAP framework, and successful integration of the licensed assays into the accredited workflow. Key risks include routine accreditation audits and the need to translate research biomarkers into robust clinical assays under these regulatory and quality systems.
Concrete items to watch include the operational launch and clinical deployment of LDTs from the Bothell lab, any formal test offerings tied to the pancreatic and breast cancer licenses, and follow-up scientific outputs after the AACR presentation on the circulating cell-free DNA biomarker (presented
Taipei, Taiwan, Oct. 10, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that its business partner, EG Biomed US Inc. (“EG BioMed”) one of the Company’s licensing partners for pancreatic and breast cancer detection and with 3D Global to develop treatment for eye disorders, has been accredited by the College of American Pathologists’ (CAP) Laboratory Accreditation Program for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600).
CAP accreditation, widely recognized as the gold standard in laboratory quality assurance, confirms that EG BioMed meets the highest standards of excellence in laboratory operations. Together with its existing CLIA certification, this recognition further strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) in support of YD Bio’s cancer detection programs and diagnostic innovations in the U.S. market.
“We are thrilled to see our partner company, EG BioMed, achieve this prestigious recognition,” said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio Limited. “CAP accreditation underscores our commitment to improving patient outcomes through scientific innovation and precision, and it strengthens our ability to deliver accurate, reliable diagnostics to patients, and further establishes us as a trusted leader in precision diagnostics. This achievement represents an important step toward our mission of delivering innovative solutions that enhance quality of life and save lives.”
With CAP accreditation secured, YD Bio and EG BioMed are well positioned to expand their diagnostic portfolio, focusing on early cancer detection and monitoring. Along with YD Bio’s ophthalmology products and other breakthrough healthcare solutions, the Company continues to advance its mission to improve patient outcomes and quality of life.
Further underscoring ED BioMed’s scientific leadership, Ruo-Kai Lin, Chief R&D Officer of EG BioMed and Professor of Taipei Medical University, presented new findings at the American Association for Cancer Research (AACR) special Conference on Advances in Pancreatic Cancer Research, held in Boston from September 28 to October 1, 2025. Her presentation highlighted a novel circulating cell-free DNA biomarker with potential to monitor metastasis and disease progression in advanced pancreatic cancer.
About YD Bio Limited
YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company’s website: ir.ydesgroup.com
Forward-Looking Statements
Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio’s business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio’s current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in YD Bio’s registration statement and other filings with the U.S. Securities and Exchange Commission.
For investor and media inquiries, please contact:
YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com
FAQ
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